Health TrialsbyHealthPanel

A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.

Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.

No evidence of recurrent or metastatic disease after surgery.

ECOG performance status of 0 or 1.

Disqualifiers

Tumor clinical stage IV (metastatic) breast cancer.

History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.

History of severe pulmonary disease, such as interstitial lung disease.

Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-8080 Tablets

    Drug

    HRS-8080 tablets.

  • Letrozole tablets

    Drug

    Letrozole tablets.

  • Tamoxifen Citrate Tablets

    Drug

    Tamoxifen Citrate tablets.

  • Anastrozole Tablets

    Drug

    Anastrozole tablets.

  • Exemestane tablets

    Drug

    Exemestane tablets.

Treatment groups

5,500 Participants
are divided into 2 treatment groups
Group A: HRS-8080 GroupExperimental treatment 1 intervention
Group B: Standard endocrine therapy GroupActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause.

Invasive Breast Cancer-Free Survival (IBCFS).

Time frame
At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.

Secondary outcomes

1

Invasive Disease-Free Survival (IDFS).

Time frame
At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
2

Distant Metastasis-Free Survival (DRFS).

Time frame
At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
3

Overall Survival (OS).

Time frame
Survival follow-up every 3 months, up to 5 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now